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临床试验/NCT01789502
NCT01789502已完成不适用

Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?

Inje University6 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
6
主要终点
Adverse events related to the stent insertion

研究概览

简要总结

This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.

详细描述

Pancreaticoduodenectomy is curative option in periampullary tumor. Preoperative endoscopic retrograde cholangiopancreatog-raphy (ERCP) is usually undertaken in patients with resectable disease to relieve biliary obstruction, which is thought to impair immune response, clotting, and other functions that impact intraoperative and postoperative outcomes. Despite conflicting data pertaining to preoperative biliary drainage, ERCP with biliary stenting has become standard practice in patients with periampullary malignancies. In a recent multicenter randomized trial, patients who underwent preoperative biliary drainage had a 74% rate of complications compared with 39% for those who directly underwent surgery without preoperative biliary drainage. In this trial, however, all patients underwent placement of plastic stents. In ERCP, self-expandable metal stent are being increasingly placed for palliation of malignant biliary obstruction. Compared with plastic stents, self-expandable metal stents have large caliber and have demonstrated longer patency duration. Even in patients with resectable malignant disease, self-expandable metal stents which are placed below the level of transection may not impair technical outcomes at surgery and can be safely removed along with the surgical specimen.

This prospective study is designed to compare the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays in patients with periamupllary tumors who are undergone with self-expandable metal stents or plastic stents placement for preoperative biliary drainage

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 20 years old of age
  • Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer
  • No evidence of distant metastases or locally advanced tumor

排除标准

  • Unresectable stage of cancer
  • Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis)
  • Severe gastric outlet obstruction or duodenal obstruction
  • Severe comorbidity (Karnofsky<50%)

结局指标

主要结局

Adverse events related to the stent insertion

时间窗: up to 4weeks

Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.

次要结局

  • Re-intervention rate(up to 4weeks)
  • Hospital stay(up to 1months)
  • Surgical outcomes(up to 1months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tea Jun Song

Assistant Professor

Inje University

研究点 (6)

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